Summary

Artivion, Inc. is a leading medical device company specializing in cardiac and vascular surgical technologies with a primary focus on aortic disease treatment. Founded in 1984 and headquartered in Kennesaw, Georgia, the company operates as a publicly traded entity on the NYSE under the symbol AORT. Artivion develops, manufactures, and distributes a comprehensive suite of aortic-centric solutions including cryopreserved cardiac and vascular allografts, surgical sealants like BioGlue, prosthetic heart valves (including the On-X mechanical heart valve), and aortic stents and stent-grafts. With over 1,600 employees globally and manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany, the company maintains sales representation in over 100 countries. Artivion's mission centers on partnering with surgeons to restore patient health through innovative technologies of unsurpassed quality, specifically targeting complex aortic pathologies through their specialized product portfolio that addresses critical challenges in cardiovascular surgery.

Job description

Responsibilities

Complete intermediate reviews of donor records and have the authority to make decisions to pass donors to the next review per relevant standards / SOPs based on review and discretion.
Provide support to DQA Analysts and Technicians with donor chart and eligibility questions to accurately complete donor chart reviews or process recovery partner charting information.
Assist management with training functions as deemed necessary to ensure Quality personnel are current to updated standards, procedures, and specifications.
Ensure donor charts are controlled and meet required quality specifications and regulatory standards prior to release.
Timely evaluation and disposition of issues concerning nonconforming donors.
Develop systematic methods for completing work assignments to ensure timelines are met and personal job commitments are accomplished.
Perform responsibilities of Analyst as needed.
Understand ISO requirements, AATB, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification, etc.
Aid management in assuring that specifications, procedures are periodically reviewed for accuracy, validity and functionality, and when necessary, initiate the required changes.
Provide input to management to facilitate the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job. Initiate change requests and change orders.
Ability to lead and present ideas that are motivating, by maintaining positive support from associates, by setting a positive example, and by establishing an overall objective and creative atmosphere.
Effectively complete "other" functions that may be assigned.

Qualifications

Bachelor's Degree in the Life Sciences or other scientific field OR 3 years experience in tissue industry and/or handling medical records
1 year experience as Donor Quality Assurance Analyst required
Certified Tissue Bank Specialist (CTBS) certification preferred

Requirements

Bachelor's Degree in the Life Sciences or other scientific field OR 3 years experience in tissue industry and/or handling medical records
1 year experience as Donor Quality Assurance Analyst required
Certified Tissue Bank Specialist (CTBS) certification preferred

Company overview

Artivion, Inc. is a leading medical device company specializing in cardiac and vascular surgical technologies with a primary focus on aortic disease treatment. Founded in 1984 and headquartered in Kennesaw, Georgia, the company operates as a publicly traded entity on the NYSE under the symbol AORT. Artivion develops, manufactures, and distributes a comprehensive suite of aortic-centric solutions including cryopreserved cardiac and vascular allografts, surgical sealants like BioGlue, prosthetic heart valves (including the On-X mechanical heart valve), and aortic stents and stent-grafts. With over 1,600 employees globally and manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany, the company maintains sales representation in over 100 countries. Artivion's mission centers on partnering with surgeons to restore patient health through innovative technologies of unsurpassed quality, specifically targeting complex aortic pathologies through their specialized product portfolio that addresses critical challenges in cardiovascular surgery.